NCT05742152

Brief Summary

This project aims to provide values of test-retest reliability and insights from concurrent validity of outcome measures for pain in multiple sclerosis.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

January 28, 2023

Last Update Submit

July 11, 2024

Conditions

Pain

Keywords

Pain, outcome measure, assessment, multiple sclerosis, reliability, validity

Outcome Measures

Primary Outcomes (1)

  • Douleur Neuropathique 4 (DN4) Questionnaire

    screening tool

    Day 1 and day 7

Secondary Outcomes (1)

  • PainDETECT Questionnaire

    Day 1 and day 7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People with MS with pain

You may qualify if:

  • Age 18 and above,
  • Ambulatory pwMS with definite diagnosis based on McDonald criteria
  • Expanded Disability Status Scale of 6.0 or below,
  • Having pain in last month
  • Able to understand and answer the questions in the questionnaires.

You may not qualify if:

  • Diagnosed with major musculoskeletal disorder and any neurological disorder other than MS,
  • a relapse in the last month before enrolment,
  • cognitive decline that renders the patient incapable of performing tests and questionnaires,
  • patients with only headache

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National MS center

Melsbroek, Brabant, 1820, Belgium

Location

Noorderhart

Overpelt, Limburg, 3900, Belgium

Location

AZ Sint-Jan

Bruges, Belgium

Location

Pontificia universidad catolica de Chile

Santiago, Chile

Location

Related Publications (1)

  • Yilmazer C, D'haeseleer M, Soler B, Van Wijmeersch B, Solaro C, Ciampi E, Carcamo C, Van Asch P, Cambron M, Lamers I, Feys P. Assessing pain in multiple sclerosis: Test-retest reliability of patient-reported outcome measures and accuracy of screening tools. Mult Scler. 2025 Apr;31(4):474-488. doi: 10.1177/13524585241310139. Epub 2025 Jan 16.

    PMID: 39819131DERIVED

MeSH Terms

Conditions

PainMultiple Sclerosis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 23, 2023

Study Start

April 1, 2023

Primary Completion

April 23, 2024

Study Completion

May 1, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations

CL(1)BE(3)